Roles and Responsibilities
- Complete data entry in safety database including writing of adverse event narrative and preliminary assessment of event seriousness and expectedness / listedness as per Reference Safety Information. Documents will be in Japanese Language
- Generate adverse event queries, liaise with the medical reviewers and clients to agree upon the queries, and send request for additional information to the sites/reporter.
- Engage with the Site Monitors to ensure follow up information is obtained from site effectively.
- Forward safety report documents to designated medical reviewer for review.
- Forward completed safety report documents to clients and other relevant parties.
- Foster constructive and professional working relationships with all project team members, internal and external.
- File documents according to project specific requirements (electronically or in hard copy as applicable).
- Ensure case files are compliant with SOPs.
- Interact and communicate effectively with other company departments/functions such as project management field monitoring, data management, etc. to ensure the highest level of client satisfaction through successful execution of projects.
- Perform literature review as appropriate for Post-Marketing cases.
- Maintain knowledge of legislation, guidelines and regulations relating to safety and PV reporting applicable to countries where Syneos Health Clinical manages safety responsibilities.
- Provide support for PV Lead with miscellaneous project tasks relating to safety reporting.
- Participate in audits as required/appropriate.
Any other duties as assigned by manager
Desired Candidate Profile
- The candidate must be certified in Japanese Language Proficiency Test (JLPT). Candidates with JLPT Level 1 to 5 will be eligible.
- Person should know to read and write Japanese (Mandatory)
- Role requires the candidate to translate/interpret information from Japanese to English and English to Japanese for teams
- Candidate must have a good grasp over Japanese language
- Preferred having Good Understanding in medical terminology
Computer proficient including experience with Microsoft Office Suite, including but not limited to word processing software (MS Word), presentation software (MS Power rpoint), email software (Outlook), and spreadsheet software (MS Excel
Skills Required: Clinical Research,Pharma,Biotech,Japanese Language Specialist,JLPT